Model Number 3788 |
Device Problem
Delayed Charge Time (2586)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Sjm has limited information related to the patient¿s medical history and is unable to form an opinion as to the relevancy of the patient¿s history to the event reported.Sjm defers to the patient¿s physician regarding medical history.Udi (di): (b)(4).
|
|
Event Description
|
It was reported the patient experienced increasing ipg recharge burden.As a result, the patient will undergo surgical intervention.
|
|
Event Description
|
Follow-up revealed the ipg was explanted and replaced on (b)(6) 2016.The issue was resolved by surgical intervention.
|
|
Search Alerts/Recalls
|